510(k) Report

510(k) · Cleared

Cleared

Modification to Titanium Tri-Lock Hips Stem

K010367510(k) SpecialCleared Mar 9, 200130-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

DePuy Orthopaedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Mar 9, 2001 as substantially equivalent to K001982 (DePuy Orthopaedics, Inc., 2000) after a 30-day review. Its family tree reaches back 1 generation to 2000. 31 later devices descend from it.

Decided
Mar 9, 2001
Review
30 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001982 (2000). 31 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2016: 4 descendants cleared2012: 1 descendant cleared2014: 4 descendants cleared2013: 2 descendants cleared2021: 3 descendants cleared2018: 1 descendant cleared2020: 2 descendants cleared2025: 2 descendants cleared2015: 1 descendant cleared2019: 1 descendant cleared2017: 3 descendants cleared2023: 1 descendant cleared2022: 3 descendants cleared2024: 2 descendants cleared2026: 1 descendant clearedK001982 · Tri-Lock Hip Stem · DePuy Orthopaedics, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 17 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K001982 · Tri-Lock Hip Stem · DePuy Orthopaedics, Inc. · 20000+5
  1. Root · 1 generation backK001982 Tri-Lock Hip StemDePuy Orthopaedics, Inc. · 2000
  2. This deviceK010367 Modification to Titanium Tri-Lock Hips StemDePuy Orthopaedics, Inc. · 2001
  3. Descendant · cites it directly · 10 of its ownK121563 Corin Trifit TS HipCorin USA · 2012 · Recalled
  4. Descendant · cites it directly · 7 of its ownK152084 Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with…Corentec Co., Ltd. · 2016 · Recalled
  5. Descendant · cites it directly · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
  6. Descendant · 2 generations on · 5 of its ownK153381 Corin Metafix Hip StemCorin U.S.A. Limited · 2016 · Recalled
  7. Descendant · cites it directly · 5 of its ownK133370 Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve…Signature Orthopaedics Pty Limited · 2014

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2012: 12013: 22014: 42015: 12016: 42017: 32018: 12019: 12020: 22021: 32022: 32023: 12024: 22025: 22026: 1
2012high 4 (2014) · low 1 (2012)2026

Most influential descendants

Showing 5 of 31 · See all
  • K121563Corin Trifit TS HipCorin USA · 2012 · cites it directly10descendants
  • K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd. · 2016 · cites it directly7descendants
  • K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · cites it directly6descendants
  • K153381Corin Metafix Hip StemCorin U.S.A. Limited · 2016 · 2 generations on5descendants
  • K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited · 2014 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001982Tri-Lock Hip StemDePuy Orthopaedics, Inc.2000—
0 (this device)K010367Modification to Titanium Tri-Lock Hips StemDePuy Orthopaedics, Inc.2001—
+1K121563Corin Trifit TS HipCorin USA20121
+1K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with…Corentec Co., Ltd.20161
+1K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.20161
+2K153381Corin Metafix Hip StemCorin U.S.A. Limited20161
+1K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip…Signature Orthopaedics Pty Limited2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201320
201440
201510
201640
201730
201810
201910
202020
202130
202230
202310
202420
202520
202610
FIG. 1 — Lineage of K010367, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K001982Tri-Lock Hip StemDePuy Orthopaedics, Inc.2000—

What descends from it? (31)

See all 31

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121563Corin Trifit TS HipCorin USA201210
K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.20167
K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.20166
K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145
K131022Ovation 10/12 Hip StemOrtho Development Corp.20135

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K121563 (Corin USA, 2012) has gone furthest, with 10 descendants of its own.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis…

Read the full statement (103 words)

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by

replacing the damaged hip joint articulation in patients where there is evidence of sufficient

sound bone to seat and support the components. Total hip replacement is indicated in the

following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,

theumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation,

arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip

replacement.

5. Certain cases of ankylosis.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

Recent decisions in LPH

The LPH category page

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  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
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https://510kreport.com/device/K010367 · printed Nov 3, 2026

Cite this page

510(k) Report. “K010367: Modification to Titanium Tri-Lock Hips Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K010367

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026